A Study to Find Out How Nusinersen is Processed in the Body When Given Through the ThecaFlex DRx™ System in Adult and Pediatric Participants With Spinal Muscular Atrophy (PIERRE-PK)

ClinicalTrials.gov ID: NCT06555419

Public ClinicalTrials.gov record NCT06555419. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Jul 22, 2026, 2:01 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open Label, Single Cohort Study to Assess the Pharmacokinetic Profile of Nusinersen (BIIB058) Administered Via the ThecaFlex DRx™ System (PIERRE-PK)

Study identification

NCT ID: NCT06555419
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1
Lead sponsor: Biogen; Industry
Enrollment: 58 participants

Conditions and interventions

Conditions

Muscular Atrophy, Spinal

Interventions

Nusinersen Drug
ThecaFlex DRx System Device

Drug · Device

Eligibility (public fields only)

Age range: 3 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jan 15, 2025
Primary completion: Jun 24, 2027
Completion: Jun 24, 2027
Last update posted: Mar 17, 2026

2025 – 2027

United States locations

U.S. sites: 10
U.S. states: 7
U.S. cities: 10

Facility	City	State	ZIP	Site status
Children's Hospital of Orange County	Orange	California	92868	Recruiting
Stanford University Medical Center \| Department of Neurology_Palo Alto	Palo Alto	California	94304	Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois	60611-2605	Recruiting
Boston Children's Hospital	Boston	Massachusetts	02115	Recruiting
Helen DeVos Children's Hospita	Grand Rapids	Michigan	49503	Recruiting
Milton S. Hershey Medical Center \| Pennsylvania State University_Hershey	Hershey	Pennsylvania	17033	Recruiting
Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	19104	Recruiting
Texas Childrens Hospital Houston	Houston	Texas	77030	Recruiting
Stacey Hall Developmental Pediatrics	Charlottesville	Virginia	22903	Recruiting
Children's Hospital of the King's Daughters_Norfolk	Norfolk	Virginia	23507	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 9 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06555419, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Mar 17, 2026 · Synced Jul 22, 2026

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The complete protocol, eligibility criteria, and contact information for NCT06555419 live on ClinicalTrials.gov.

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